- Lead tasks as assigned by manager with decisiveness and strong judgment.
- Select, contract, and monitor non-GLP and GLP-outsourced nonclinical studies at Contract Research Organizations (CROs).
- Manage CRO contracts and SOWs from RFP to approval through execution.
- Coordinate drug delivery to CROs in conjunction/collaboration with our internal Pharmaceutical Science and Technology (PST) team representatives.
- Coordinate the receipt of study samples with Visterra BioAnalytical team; oversee distribution, inventory, and archiving.
- Create and maintain timelines for nonclinical studies.
- Maintain accurate and complete data management and document archiving of all nonclinical studies.
- Display a proven ability to meet deliverables and timelines.
- Work collaboratively with internal and external cross-functional teams or stakeholders, for example Regulatory and PST.
- Occasionally travel to monitor outsourced studies, participate in professional meetings, and engage with current and potential vendors (less than 10% travel).
- Bachelor or higher degree in scientific-related field, and at least 3 years of experience in toxicology, pharmacology, pharmacokinetics, immunology, biological sciences, or related discipline.
- Experience with Smartsheet, Agiloft Contract Management System, and SAP BusinessByDesign is preferable but not required.
- Strong study management track record; experience in nonclinical project management a plus.
- Excellent oral, written presentation and communication skills.
- Excellent interpersonal, organizational, and problem-solving skills required to manage multiple responsibilities at the same time.
- Solid understanding of animal welfare regulations (IACUC, USDA, and OLAW).
- Experience in outsourcing and managing CROs for regulated (GLP, GxP) studies.
- Managerial experience and demonstrated effective leadership within cross functional teams.
- The ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across a broad spectrum of audiences both internal and external, and excellent written skills.
- Demonstrated ability to be a team player who thrives in a fast-paced environment and takes the initiative to identify, analyze and resolve issues.
- Familiarity with biologics is highly desirable.
- Familiarity with regulatory requirements, including GLP, GxP, ICH and other applicable guidelines for Nonclinical development in support of clinical trials.
- A 401(k)-retirement plan with a 10% dollar-for-dollar match.
- Medical, dental and vision benefits, with Visterra contributing 85% to the monthly premium.
- A rich mental & behavioral wellness program.
- Short- and long-term disability programs.
- Group and voluntary life insurance.
- Pre-tax flexible spending and commuter accounts.
- 17 days of personal time, discretionary sick time, and 11 holidays per calendar year. Personal time accrual grows to 22 days after 3 years, with an additional one-time grants of 5 days every 5 years.
- Twelve weeks of paid parental leave for birth or adoption.
- A broad fitness reimbursement program.
- Tuition and student loan reimbursement.
- A variety of employee discounts.
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Associate Manager, Preclinical Development - Waltham, United States - Visterra
Description
Job Description
Job DescriptionSalary:The Opportunity
Visterra, Inc. is seeking a collaborative, enthusiastic, and engaging Associate Manager with a strong scientific background and previous vendor management experience to join our dynamic Preclinical Development team. The Associate Manager is a key member of the team who will help support the transition of drug development candidates through nonclinical studies (in both a regulated and non-regulated setting) into early clinical studies. The Associate Manager reports to the Manager, Preclinical Development. The primary focus for this role will be study placement and monitoring, managing contracts and departmental databases/records, and providing technical oversight. This individual will work a great deal independently as well as cross-functionally within Visterra.
The successful candidate will demonstrate a proven track record in drug development and have experience with biologics and understanding of INDs and FDA/EMA guidelines. This individual will be highly analytical, goal-oriented, and timeline sensitive while maintaining high quality standards. This role will require occasional early morning and evening virtual meetings.
Responsibilities
Requirements
Benefits
We provide comprehensive benefits and resources to support your work, life, and balance.
About Us
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.
Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 115 employees and is in Waltham, Massachusetts.
Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Associate Manager, Preclinical Development professionals in Waltham
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Jessie Delorey
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Matthew Morin
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Nam Nguyen
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